European Biotechnology News 7/2012 - Free Excerpt - The biosimilar slugfest

Nº 7-8 | Volume 11 | 2012 | 10.00 € | ISSN 1618-8276 | A 60711 |

European Biotechnology News Science & Industry

CENTRAL EUROPE

AC Immune expands Alzheimer’s partnership with Roche NORTHERN EUROPE

Nordic states to accelerate clinical multi-centre trials

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The biosimilar slugfest

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New concepts in Personalised Medicine WESTERN EUROPE

Translational stem-cell centres join forces SOUTHERN EUROPE

Technophage to develop arthritis drug with Chinese partners EASTERN EUROPE

Mabion selects sales partners for copycat rituximab SCIENCE & TECHNOLOGY

Pharma firms crack defenses of antibiotic-resistant bacteria

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Editorial

Biosimilars and biologics for Europe and the world Erik Bogsch, Managing Director, Gedeon richter Plc., Budapest, Hungary

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Erik Bogsch is the Managing Director of Gedeon richter Plc., a leading European specialty pharma company, as well as Chairman of the Board at the Hungarian Pharmaceutical Manufacturers Association. He holds a degree in chemical engineering and economic engineering. Bogsch began his career at richter in 1970 in r&D managerial positions, and became CEo in 1992. He was fundamental in turning the firm into a major multinational company. His achievements and efforts to promote Hungarian innovation have been recognised with a number of awards.

wenty-eight percent of the products given marketing authorisation between November 2010 and October 2011 in the US and one-third of all the new drugs in the EU have biotechnological origins. And experts unanimously agree that the market share of biotechnology products will continue to grow in the future. While the small-molecule drug market is predicted to expand by 3.9% annually between now and 2015, the market for biopharma products is expected to grow by more than 10% a year. The trend is further bolstered by the fact that approximately one-third of current clinical development projects are of biotechnological origin. According to expert estimates, seven of the world’s top ten drugs will be of biotechnological origin by 2016. Based on the above, it can be firmly stated that biotech medicines are making a substantial contribution to the world’s healthcare system, including that of Eastern Europe.

The most appropriate way to ensure affordable biological medicines is the use of biosimilar versions of new biological entities after patent protection has run out. These products have a very similar biological profile – including efficacy, safety and tolerability – and they are, of course, cheaper. The EU was the first to introduce this type of regulatory pathway, but now several other countries, including the US and Japan, apply a regulatory approach that differs in only minor ways.

These forecasts and data unequivocally support Richter’s strategic decision to set up a biotechnology portfolio. Our aim is to create a complex and competitive biopharma line that will help expand the company’s portfolio with high added-value products, and we are making great progress in establishing the infrastructure supporting the development of biosimilar products. In 2007, Richter and Helm AG es-

tablished a joint venture for the development and manufacture of microbial proteins. A biotechnology pilot plant with the capability to develop biosimilar versions of monoclonal antibodies went operational at our Budapest site in 2009. Most importantly, Richter’s new biotechnology plant in the Hungarian city of Debrecen was completed and officially inaugurated in April. The state-of-the-art €84m facility will initially produce samples for clinical tests with the use of mammalian cells, and will begin to manufacture drugs for treating human diseases in 2014. The plant will later produce proteins and antibodies for fighting cancer and chronic inflammatory diseases.

The governments of nearly all CEE countries have recognised the high priority and important role of biotechnology among innovative technologies, and some of them (including Hungary) have made it a vital part of economic development plans. In this respect, Richter’s strategic move was definitely in harmony with the intention of CEE countries and, in a wider context, the world itself.

Exploring new areas is always a risky proposition. Still, I am confident that Richter’s forward-looking innovative spirit will help us achieve our goal: a biosimilar-enforced product portfolio that can help to improve quality of life for even more patients, whether they live in Eastern Europe or anywhere else on the planet.

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European Biotechnology News is published in co-operation with the following organizations: European Biotechnology

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Net work

Europe: european-biotechnology.net

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EuroBiotechNews covers the biotechnology sector of the current 27 EU member states, Norway and Switzerland. If you would like to subscribe, please refer to Portugal: www.apbio.pt

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Cover Story © laurent hamels/fotolia.com

Heard in Brussels; EMA adopts new conflict-of-interest rules 10 Research Ministers back Horizon 2020 11 IP Flash; EFPIA criticises Germany’s health technology assessment

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IMI launches new call and projects

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RegulatoRy affaIRs Breaking news from the EMA

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Update on clinical trials

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How Big Pharma is coping with the biosimilar threat

ecoNomIc Focus on newsflow and dividends

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Stock markets

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PeRsPectIVes

In just a few short years, many Big Pharma biologics manufacturers will be seriously out of pocket when their blockbuster compounds go off patent. Or will they? Although slow to react, many pharmaceuticals heavyweights have moved into the offensive to stave off huge potential losses. Now they are setting up biosimilar arms of their own, while many are reinventing their antibodies to perform as highly-specific delivery systems for tumour-killing therapeutics. Can ADCs take mABs to the next level?

Interview: Franck Molina, European Diagnostics Clusters Alliance 31

Northern Europe Denmark, Sweden, Finland, Norway 20 Central Europe Germany, Austria, Switzerland Western Europe UK, France, the Netherlands

seRVIces

SpeCial

RegIoNal News

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Personalised Medicine Personalised Medicine market growth and opportunities

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Biobank Graz – a hub for competitive research

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Pharma and diagnostic firms share wider horizons

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Southern Europe Italy, Spain, Portugal, Cyprus, Greece 28

Synergy COPD project reaches first major milestone

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Eastern Europe Poland, Hungary, and the Czech Republic

Cell transplantation: using progenitor cells for repair

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Partners & Associations

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Imprint

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Biopeople News from Molecular Partners, InDex Pharmaceuticals, Medivir AB, Shire plc, and the Accademia dei Georgofili in Florence 32 Company index

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Events What’s on in July-August 2012

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Encore

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Imprint European Biotechnology News is published monthly by: BIOCOM AG, Lützowstr. 33–36, D-10785 Berlin, Germany, Tel.: +49-30-264921-0, Fax: +49-30-264921-11, E-Mail: service@eurobiotechnews. eu; Internet: www.eurobiotechnews.eu, Publisher: Andreas Mietzsch, Editorial Team: Thomas Gabrielczyk (Managing Editor), Derrick Williams (Co-editor), Dr. Patrick Dieckhoff, Dr. Philipp Graf, Dr. Bernd Kaltwaßer, Dr. Martin Laqua; Advertising: Oliver Schnell, +49-30-2649-2145, Advertising USA: Avani Media, Inc. , Leslie Hallanan, Tel.: +1-415-331-2150 , Fax: +1-415-289-0402, E-Mail: leslie@avanimedia.com; Distribution: Angelika Werner, +49-30-2649-2140; Printed at: Druckhaus Humburg, Bremen; Graphic Design: Michaela Reblin. European Biotechnology Science & Industry News is only regularly available through subscription at BIOCOM AG. Annual subscription fees: € 100.00, Students € 50.00 (subject to proof of enrolment). Prices include VAT, postage & packaging. Ordered subscriptions can be cancelled within 2 weeks directly at BIOCOM AG. The subscription is initially valid for one year. Subscriptions will be renewed automatically for one more year, respectively, unless they are cancelled at least 6 weeks before the date of expiry. Failures of delivery which BIOCOM AG is not responsible for do not entitle the subscriber to delivery or reimbursement of pre-paid fees. Seat of court is Berlin, Germany. As regards contents: individually named articles are published within the sole responsibility of their respective authors. All material published is protected by copyright. No article or part thereof may be reproduced in any way or processed, copied and proliferated by electronic means without the prior written consent of the publisher. Cover Photo: © laurent hamels/Fotolia.com ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

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Heard in Brussels M

Is Europe truly ready for a bioeconomy?

Brussels – Bioeconomy is the new health, and that is official. You only have to look at all the planning for Horizon 2020 and all the big words coming out of politicians at national and European levels to see that. But is Europe really ready or willing to embrace what it will take to replace existing technologies with new, bio-driven ones?

Let’s look at one example: biofuels.

We’re talking about a sector where the global players in fuel production and oil supply are not bit players. They dominate the global economy, and sit at the right hand of presidents and prime ministers. None of these organisations have made a significant shift into biofuels. A fraction of the money spent on discovery programmes transferred into biofuel production would revolutionise global production and supply. But do you think that they are going to make it easy for other organisations to change policy and start eroding market share?

significant public funds needed There is also no escaping the fact that new technologies will need significant public funds to create a platform from which to grow. They are not going to make it on a purely commercial basis.

Opponents already harp on this, forgetting the massive subsidies – disguised or otherwise – that other energy industries have soaked up over the years. Solar panels are the perfect example here.

Look what happened to the sector when subsidies were cut by cash-strapped governments.

Are European governments going to create this funding? It will have to be big, sustained and commit to a new energy platform over others. Interestingly, biofuel production from crops will have to take place close to the source of the crops. The economics don’t add up

Claire skentelbery, secretary general of the European Biotechnology Network

to ship carbon sources long distance, so you are producing locally for local consumption. That changes the game for energy production, turning it from a global market into a national one, which makes for interesting prospects in Europe. Will we invest in national production infrastructure and realign our agricultural production to supply facilities?

This goes far beyond nice words about reducing dependence on fossil fuels. It requires wholesale commitment.

It works in economies with massive crop waste supplies and little or no domestic oil/gas industry. This could point to regions other than Europe as the future for biofuel production. And the irony is that these countries will embrace GM crops that improve fuel production from crop waste, where Europe is still having hissy fits about potatoes for starch production.

This could be a revolution in Europe, but we will need to seize it with both hands and make major changes to the agricultural production system across all countries, expanding farm to fork to include farm to fuel-tank. Think we can handle that?

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EMA

New breaches of trust policy A strasbourg/parma – Europe’s drug regulator EMA has adopted new rules to prevent conflicts of interest or incomplete declarations of interest among its board members. Designed to ensure that strategic decisions and activities of the Agency are not affected by pharmaceutical industry interests, the special rules complement guidelines adopted this March to prevent conflicts of interest among the EMA’s scientific experts and staff. The European Parliament recently refused to discharge the 2011 EMA budget until concerns over the impartiality of its Board and Committee members – as well as its staff – were resolved (see EuroBiotechNews 6/2012).

According to the updated standards, board members may neither work with nor consult pharma companies. They may not own a patent, have any financial or other interests in such firms, or participate in their development as members of advisory boards. They are also not allowed to be involved in either research or clinical development at a company. However, members of the EMA’s board are allowed to provide scientific advice in their function as head of a national authority of a member state.

Any “current direct interest(s) in the pharmaceutical industry are incompatible with involvement in the activities of the Board,” say the new EMA rules. Board members have to declare all potential conflicts of interest concerning employment, strategic advisory roles, consultancy or financial interests dating back five years.

Furthermore, any industry interests affecting a board member’s household must also be declared. If a board member intends to become engaged with the pharmaceutical industry during his term, as occurred with former EMA head Thomas Löngrenn (see EuroBiotechNews 6/2012), he/she is obliged to inform colleagues immediately. In the future, board members will be informed of any declared new interests at the beginning of each meeting.

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Public-Private PartnershiP

Sweetening the pot on pressing issues

© sergej Khackimullin/Fotolia.com

the Innovative Medicines Initiative (IMI) has launched a a224m call to develop drugs in the fight against bacteria that have become resistant to common antibiotics. the public-private partnership, which connects Eu funding with in-house research budgets at 32 big pharma majors, has also announced details on seven new projects that will be funded with a215m.

the Innovative Medicines Initiative is a joint undertaking of the pharma association EFpIA and the European Commission. Its aims include overcoming bottlenecks in the drug development process.

Most pharma companies have left the field of antibiotic development, partially due to regulatory hurdles with inferiority trials, but mostly because return on investment is poor. After all, antibiotics are only taken for a short period of time, and they cure their target disease. A new project is now offering them an economical way to pursue much-needed novel compounds to fight a skyrocketing number of resistant strains.

The IMI’s funding call is part of the EU’s “Action plan against antibiotic resistance”, which is providing a600m in cash for re-

search over the next seven years. Within two subtopics (“Innovative Trial Design” & “Clinical Development”) of the programme “Combating Antibiotic Resistance: NewDrugs4BadBugs” (ND4BB), the European Commission is to channel a109m into IMI consortia. Additionally, five EFPIA member firms (GlaxoSmithKline, AstraZeneca, Basilea, Janssen-Cilag and Sanofi) will add in-kind contributions of a114.7m. Most of the ND4BB money will go into the development of late-stage clinical drug candidates developed by the pharma contrib-

utors. a192m alone will be fed into four Phase III studies with GSK’s peptide formylase blocker GSK1322322. Trials with AstraZeneca’s polyclonal anti-TNFa antibody fragment AZD9773 will be funded within the framework of an extra call. A budget of a24m is reserved to improve drug delivery of antibiotics that are directed against Gram-negative bacteria, for which no new drug class had been established since the 1970s. IMI’s chief Michel Goldman called ND4BB a unique opportunity for researchers in biotech SME and academia to speed up their research by benefiting from the pharmaceutical industry’s development know-how.

Launching seven new projects In mid-June, the IMI also announced details on seven projects that will be funded with a total budget of a215m within the next five years. Two of them will be coordinated

by GSK. One is the model-based preclinical development of anti-tuberculosis drug combinations (PreDiCT-TB), which will aim to make tuberculosis treatments more patient-friendly. The other will focus on the development of tools to predict immune response to biopharmaceuticals (ABIRISK).

Sanofi is coordinating the DIRECT project to research patient stratification for personalised Type II diabetes treatments. Novartis AG and the University of Surrey (UK) are developing biomarkers to test the safety of vaccines (BIOVACSAFE). A project coordinated by AstraZeneca is to deliver tests for drug-induced liver injury (MIP-DILI).

And finally a consortium coordinated by Roche will seek to establish research tools and diagnostics for autism spectrum disorder (EU-AIMS).

Cost-sharing between the European Commission and EFPIA firms will also make it possible to launch an education and training project called EUPATI (European Patients’ Academy on Therapeutic Innovation). Its aim is to educate patients and the public about drug development, and empower patients to engage more effectively in the drug development process. This latest wave of announcements means the IMI is now supporting a total of 30 projects with a combined total cost of over a650m.

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CompaNy aNd adVertiser iNde x 4SC AG (GER) ………………………………… 18

a Abbott Laboratories (USA) …………………… 16 Ablynx NV (B) ………………………………… 17 AC Immune SA (CH) …………………………… 22 Actelion AG (CH) ……………………………… 31 Active Biotech AB (S) ……………………… 16, 21 Adenium Biotech (N) ………………………… 20 Affitech (DK) …………………………………… 18 Agendia B.V. (NL) ……………………………… 26 aicep (PT) ……………………………………… 28 Alexion Europe SAS (F) ………………………… 15 Algeta ASA (N) ………………………………… 20 Almirall S. A. (E) ………………………………… 15 Amgen Europe B.V. (NL) ………………………… 6 Amgen Inc. (USA) ……………………………… 31 AmsBio (UK) …………………………………… 47 Ark Therapeutics (UK) ………………………… 16 ASEBIO (E) ……………………………………… 9x Astellas Pharma Europe B.V. (NL) …………… 19 AstraZeneca (UK) …………………… 8, 12, 14, 31

B Basilea Pharmaceutica (CH) ………………… 12, 19 Bavarian Nordic A/S (DK) ……………………… 21 Bayer AG (GER) ……………………………… 8, 20 Beckman Coulter (UK) ………………………… 47 Bejing Genomics Institute (VRC) ……………… 24 Berlin Partner GmbH (GER) …………………… 13 Bibby Scientific (UK) …………………………… 47 BIO Deutschland e.V. …………………………… CP3 BIO.NRW (GER) ………………………………… 27 Biobank Graz (A) ……………………………… 38 BIOCOM AG (GER) …………………… 17, 34, 41 Biogen Idec (USA) ………………………………… 8 Biogenera srl (IT) ……………………………… 15 BioInvent International AB (S) ………………… 20 Biomax AG (GER) ……………………………… 41 Biomerieux (F) ………………………………… 17 Bioncotech Therapeutics S.L. (E) ……………… 28 Bioplanta GmbH (GER) ………………………… 23 BioProtect Research GmbH …………………… 45 BiotecArea Krems/Ecoplus (A)………………… 41 Biotest AG (GER) ………………………………… 8 Bioton S.A. (PL) ………………………………… 30 BioWin – The Health Cluster of Wallonia (B) … 25 Boehringer Ingelheim GmbH (GER) …… 6, 14, 15 Breedinvest (NL) ……………………………… 26

C Celldex Therap. Inc. (USA) ……………………… 8 Celtic Pharmaceutical Holdings L.P (UK) …… 16 Cempra Pharmaceuticals (USA) ……………… 23 Centocor BV (NL) ………………………………… 8 Chemometec A/S (DK) ……………………… 31 Cobra Biologics (UK) …………………………… 43 Concit Pharma (DK) …………………………… 21 Copernicus Sp.Zoo (PL) ……………………… 30 Cowen Healthcare Royalty Partners (USA) …… 19 Cubist Pharmaceuticals Inc. (USA) …………… 29 CuraGen Corp. (USA) …………………………… 8 Cytheris SA (F) ………………………………… 15 Cytos AG (CH) ………………………………… 31

d/e Debiopharm S.A. (CH) ………………………… 26 DFJ Venture Partners (IL) ……………………… 44 DiagnostikNet-BB (GER) ……………… 34, 37, 38 DiaSorin Deutschland GmbH ………………… 17 Dow Chemical Company (USA) ……………… 31 EarlySense (IL) ………………………………… 44 Eli Lilly Nederland B.V. ………………………… 15 Eli Lilly (USA) …………………………………… 23 Ernst & Young (GER) …………………………… 24 Erytech Pharma (F) …………………………… 26 European Biotechnology Network (B)………… 39 Executive Capital A/S (DK) …………………… 31 ExonHit (F) ……………………………………… 26

F/G Fördergesellschaft IZB mbH (GER) …………… 11 Forest Laboratories Inc. (USA) ………………… 23 Fresenius Biotech GmbH (GER) ……………… 20 Gamida Cell Ltd. (IL) …………………………… 45 GE Healtcare (UK) ……………………………… 24 Gedeon Richter Ltd. (HUN) ……………………… 3 Genentech Inc. (USA) ………………………… 22 GENOMA ESPANIA …………………………… 28 GensuPen (PL) ………………………………… 30 Gilde Healthcare Partners (NL) ……………… 26 GlaxoSmithKline (UK) ………………… 12, 14, 19 Glycotope BiotechnologyGmbH (GER) ……… 16 Grünecker Patent- und Rechtsanwälte (GER) … 14

H H. Lundbeck A/S (DK) ………………………… 31 HBM Bioventures (CH) ………………………… 23 Heidelberg Pharma AG (GER) …………………… 8 Hexal Pharma AG (GER) ………………………… 8 Hospira One 2 One (USA) …………………… CP2

i ImmunoGen Corp. (USA) ………………………… 8 IMS Health (UK)…………………………………… 8 Index Pharmaceuticals AB (S) ………………… 31 Infermed Ltd. (UK) …………………………… 41 ING Corporate Investments (B) ……………… 26 InGen BioSciences Group (USA) ……………… 26 Intercell AG (A) ………………………………… 17 IVC Research (IL) ……………………………… 45

J/K Janssen-Cilag International NV (B) …………… 12 KPMG (GER) …………………………………… 45

L Linkcare Health Services S.L. (E) ……………… 41 Lochlomond Holding (HUN) ………………… 30 Lundbeck A/S (DK) ………………………… 17, 50

m Mabion S.A. (PL) ……………………………… 30 Max-Planck-Institute of Molecular Cell Biology and Genetics – CBG……………… 48 Medarex Inc. (USA) ……………………………… 8 MediGene AG (GER) …………………………… 19 Medimmune Ltd (UK) …………………………… 8 Medivir AB (S) ………………………………… 31 Merck KGaA (GER) ………………………… 6, 44 Merck Serono (CH) …………………………… 26 Micromet AG (GER/USA) ……………………… 31 Molecular Partners AG (CH) …………………… 31

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MolMed S.p.A. (IT) …………………………… 29 Mologen AG (GER) …………………………… 18 MorphoSys AG (GER) ………………………… 31

N/o Nabriva GmbH (A) ……………………………… 23 Neuronova AB (S) ……………………………20, 29 Newron Pharmaceuticals S.p.A. (IT) ………20, 29 Nomura Phase 4 Ventures (UK) ……………… 23 Novartis AG (CH) …………………………… 16, 21 Novo Nordisk A/S (DK) ……………… 15, 17, 21, 31 Novo Seed (DK) …………………………… 20, 21 Novozymes A/S (DK) ………………………… 20 Nuevolutin A/S (DK) …………………………… 31 Omnia Molecular S.L. (E) ……………………… 50 OrbiMed Advisors (USA) ……………………… 44

p/Q/r Pfizer Ltd. (USA)……………………………6, 15, 34 PharmaMar (Grupo Zeltia) (E) …………………… 7 Porvair Sciences Ltd. (UK) …………………… 48 Promethera (B) ………………………………… 42 Proximagen (UK) ……………………………… 24 Qiagen (GER) …………………………………… 17 Roche AG (CH) ………………… 8, 16, 23, 30, 34

s Samsung (Korea) ………………………………… 6 Sandoz AG (CH) …………………… 6, 8, 23, 50 Sanofi (F) ……………………………………… 12 SAP AG (GER) ………………………………… 22 Savira Pharmaceuticals (A) …………………… 23 Scigen (SG) …………………………………… 30 Seattle Genetics (USA) …………………………… 8 Seed Capital Advisors AG (CH) ……………… 21 Shire plc (IRL)………………………………… 17, 31 Silicon Biosystems S.p.A. (IT) ………………… 29 Sothema Laboratories (MA) …………………… 30 Sunstone Life Science Venture Fonds ………… 20

t Technophage S.A. (PT) ………………………… 28 Teralys Capital (CDN) ………………………… 23 Teva Pharmaceutical Industries Ltd. (IL) …… 8, 44 Thermo Fisher Scientific (USA) ……………… 48 TMC Pharma Services Ltd. (UK) ……………… 15 Trius Therapeutics (USA) ……………………… 23 TROCKLE Unternehmensberatung (GER) …… 48 TVM Capital (GER)……………………………… 23

U/V Ubichem Pharma Services (HUN) ……………

UBS (UK) ………………………………………

UCB (B) …………………………………………

Upsher-Smith-Laboratories (USA) ……………

Van Herk Group (NL) …………………………

Vanadis Capital (S) ……………………………

Vertex Pharmaceuticals (Europe) Ltd. (UK) …

Vita 34 (GER) ……………………………………

30 17 17 24 26 21 15 23

W/x/Z Wilex AG (GER) ………………………………… 19 Wyeth (USA) …………………………………… 31 Xcellerex (USA) ………………………………… CP4 ZAMBON Group S.p.A. (IT) …………………… 29 Zeincro Hellas S.A. (GR) ……………………… 28 Zyomyx Inc. (USA) ……………………………… 31 Zytoprotec (A) ………………………………… 16

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